Q&A: The Current Status of the Indian Pharma Industry w.r.t. Hydroxychloroquine

Currently, Hydroxychloroquine (HCQ), — an anti-malarial drug being experimentally used in many countries for treating COVID-19 — is in the prime time news. Primarily because the president of the United States sees it as a viable therapeutic solution to coronavirus that has so far killed more than 10,000 Americans and infected over 3.6 lakh within weeks. Other countries also started following the same and looking for HCQ. But let’s see what the World Health Organization (WHO) recommending for this medicine.

“WHO is actively following the ongoing clinical trials that are being conducted in response to COVID-19, including studies looking at the use of chloroquine and its derivative, hydroxychloroquine, for treatment and/or prevention. Currently, there is insufficient data to assess the efficacy of either of these medicines in treating patients with COVID-19, or in preventing them from contracting the coronavirus.Chloroquine is currently recommended by WHO for the treatment of P. vivax malaria. In the context of the COVID-19 response, the dosage and treatment schedules for chloroquine and hydroxychloroquine that are currently under consideration do not reflect those used for treating patients with malaria. The ingestion of high doses of these medicines may be associated with adverse or serious adverse health outcomes.”

Through this article, we will share a few Q&As, which will help to clarify the current status of the Indian pharmaceutical industry on HCQ, along with that it will help to clear a few myths.

Ans. Hydroxychloroquine (HCQ) is a quinoline-containing anti-malarial drug used to treat or prevent malaria, a disease caused by parasites that enter the body through the bite of a mosquito.

But the drug — which can also treat auto-immune diseases like rheumatoid arthritis and lupus - has also attracted attention over the past few decades as a potential antiviral agent.

Q. Do India have enough capacity to support domestic and global supply?

Ans. The country has the capacity to quickly ramp up the output of HCQ. India manufactures 70% of the world's supply of hydroxychloroquine, according to Indian Pharmaceutical Alliance (IPA) secretary-general Sudarshan Jain.

The central government, itself has requisitioned 100 million tablets from Ipca Laboratories and Cadila Healthcare. Manufacturers claim there is enough stock for the Indian market, and that the surplus could be exported. They are gearing up to supply the same to the government within this month.

Q. What is the capacity for producing Hydroxychloroquine in India?

Ans. The country has a production capacity of 40 tons of HCQ every month, implying 20 crore tablets of 200 mg each.

Peak capacity would produce 35 crores (350 Million) tablets of 200 mg dosage every month. India's own requirement is unlikely to exceed 10 crore tablets for which the government has already placed an order with leading domestic manufacturers Zydus Cadila and Ipca Laboratories. Industry experts say 10 crore tablets are good enough to treat 7 crores (70 Million) people if required. In India, HCQ costs less than ₹3 per tablet.

Q. Any import alert is lifted to support in this crisis condition from USFDA?

Ans. Last month, the US Food and Drug Administration (FDA) partially lifted a three-year-old 'import alert' on Ipca's two plants to import the medicine. Zydus Cadila has also received an order from the US.

Q. Which pharmaceutical company can produce this drug API and formulation?

The major API makers for the drug in the country are Zydus, Ipca and Mangalam Drugs. In addition to this Abbott India, Rusan Pharma, Mangalam Drugs, Unichem Remedies, Laurus Labs, Vijayasri Organics are considered as additional contributors to produce this API.

The major formulation makers of HCQ are Ipca, Zydus, Wallace Pharmaceuticals, and Cipla.

Q. How much business India did earlier with this API and formulation?

Ans. India exported HCQ API in April-January 2019-20 period worth US$ 1.22 billion. During the same period exports of formulations made from HCQ were at US$ 5.50 billion.

Q. Can hydroxychloroquine used for COVID-19?

Ans.No, it is not a proven fact to date. But crucially there have been no complete clinical trials which are important to show how the drug behaves in actual patients, although they are underway in China, the US, UK, and Spain.

Q. Is it available Over the counter (OTC)?

Ans.No, it is a "Schedule H" drug and without prescription can’t be procured from medicine shop.

Note: Most medicines in India are labeled "Schedule H" — to be sold against prescription.OTC drugs such as paracetamol, cold and cough remedies, antacids and vitamins are categorized as OTC (over-the-counter) products that can be bought without a prescription.

Q. What would be the impact if we take this medicine without consultation with the doctor?

Ans. This drug has a different number of side effects. Use with caution in patients with gastrointestinal, neurological, or blood disorders, and in those with a sensitivity to quinine. Don’t consume the drug without consultation and evaluation with your medicinal practitioner.

About the Author:

Palash Das (ORCID ID: 0000-0002-5582-7115) is a recognized expert in the field of aseptic manufacturing of parenteral products and is a frequent presenter at several web conferences and technical training for sterile drug manufacturing. He earned his Master’s for Pharmaceutical Chemistry from the West Bengal University of Technology in India. Since 2010, Palash has been associated with a major pharmaceutical firm based in India. Outside of work, Palash runs an on-line pharmaceutical blog named Pharmaceutical Resource and Education Services, India.

DISCLAIMER: The views expressed in this insight piece are those of the author and do not necessarily reflect the official policy or position of the IndraStra Global.

References:1. Malaria and the COVID-19 pandemic, https://www.who.int/news-room/q-a-detail/malaria-and-the-covid-19-pandemic, accessed on 08-04-2020